Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers
NCT ID: NCT03667937
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
204 participants
INTERVENTIONAL
2019-05-15
2021-04-30
Brief Summary
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Detailed Description
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The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.
In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CUTIMED
After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply the CUTIMED dressing. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage.
If the wound exudate decreases, or the removal of the dressing is difficult, it will be changed to CUTIMED gel; in case of abundant exudate, the use of alginate without silver will be allowed for the treatment, because it is neutral with the bacterial load, placed on the CUTIMED dressing.
Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks).
CUTIMED
Hydrophobic Dressing
AQUACEL silver
After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply Aquacel-Ag. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage.
Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks).
AQUACEL silver
Silver Dressing
Interventions
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CUTIMED
Hydrophobic Dressing
AQUACEL silver
Silver Dressing
Eligibility Criteria
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Inclusion Criteria
1. Severe pain during dressing change
2. Perilesional edema.
3. Local edema.
4. Unpleasant smell.
5. Abundant pus
6. Microbial colonization higher than 100000 CFUs
Exclusion Criteria
* Venous ulcer with signs of infection which requires antibiotic therapy
* Venous ulcers that do not meet Lazareth and Moore criteria
* Arterial ulcers.
* Patients with type I or type II diabetes.
* Patients with immunosuppression of any etiology or in immunosuppressive treatment or with NSAIDs.
* Patients with rheumatoid arthritis in the acute phase.
* Patients with dermatitis prior to the appearance of the ulcer.
* Patients with neuropathy or lack of sensitivity of any etiology.
* Patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.
18 Years
ALL
No
Sponsors
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BSN Medical GmbH
INDUSTRY
Andalusian Health Service
OTHER_GOV
University of Malaga
OTHER
Responsible Party
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JOSE MIGUEL MORALES ASENCIO
Head of the Department of Nursing. Professor of Research and Evidence Based Health Care
Principal Investigators
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José Miguel Morales Asencio, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaga
Locations
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University of Málaga
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502.
Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. J Wound Care. 2007 Mar;16(3):129-32. doi: 10.12968/jowc.2007.16.3.27015.
Moore K, Hall V, Paull A, Morris T, Brown S, McCulloch D, Richardson MC, Harding KG. Surface bacteriology of venous leg ulcers and healing outcome. J Clin Pathol. 2010 Sep;63(9):830-4. doi: 10.1136/jcp.2010.077032. Epub 2010 Jul 29.
Moore MF. Prospective, Descriptive Study of Critically Colonized Venous Leg Ulcers Managed With Silver Containing Absorbent Dressings and Compression. J Am Coll Clin Wound Spec. 2014 Sep 16;5(2):36-9. doi: 10.1016/j.jccw.2014.08.002. eCollection 2013 Aug.
Pugliese DJ. Infection in Venous Leg Ulcers: Considerations for Optimal Management in the Elderly. Drugs Aging. 2016 Feb;33(2):87-96. doi: 10.1007/s40266-016-0343-8.
Totty JP, Bua N, Smith GE, Harwood AE, Carradice D, Wallace T, Chetter IC. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. J Wound Care. 2017 Mar 2;26(3):107-114. doi: 10.12968/jowc.2017.26.3.107.
Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011 Sep;23(9):267-75.
González-Consuegra, R.V., Verdú, J., 2010. Proceso de adaptación al castellano del Charing Cross Venous Ulcer Questionnaire (CCVUQ) para medir la calidad de vida relacionada con la salud en pacientes con úlceras venosas. Gerokomos 21, 80-87
Other Identifiers
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CUCO-UV
Identifier Type: -
Identifier Source: org_study_id
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